Validation Lead

We are looking for a Validation Lead for a biopharmaceutical manufacturing facility who's focus will be leading equipment / utility / environmental qualification onsite.

Responsibilities:

• Routine re-qualification ownership:
• CTUs: periodic temperature mapping (Fridges, Freezers, Coldrooms Incubators)
• Classified areas and utilities re-qualification. (Process GAsses CO2, O2, Air).
• Downflow booths, BSCs, LAF, Fume Hood - airflow patterns, velocities, filter
• integrity, containment checks.
• Requalification of autoclaves. (EN285).
• Select process equipment: periodic re-qualification based on criticality (e.g., parts washers, Vi-Cells., as applicable).
• New equipment introductions:
• Author Master Validation Plans; input to URS alignment and risk assessments to scope IQ/OQ/PQ.
• Execute/oversee protocols, validation discrepancies.
• Validation Summary Reports.
• Change control/Lifecycle:
• Participate in engineering change assessments; judge impact of automation/mechanical changes along with area SMEs.
• Decide verification vs. partial/full re-qualification; update protocols and validation files.
• Maintain VMP, equipment files, traceability; ensure data integrity/inspection readiness

Skills, Attributes & Experience:

• 6-7+ years' GMP experience with strong equipment/utility qualification.
• Minimum of 4 years + experience working in a Validation role within Pharmaceuticals or Medical Device.
• Hands-on with temperature mapping, cleanroom and utilities re-qualification.
• Ownership mindset with high drive and accountability - "run it like you own it," proactively solving problems and pushing validation activities to completion.